FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results
BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical diagnostic device with the potential for false positive results. No hospitalizations, illnesses, or injuries have been reported. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported,' yielding a severity score of 3.
Plain-English summary
BioFire Diagnostics, LLC is recalling the FilmArray Pneumonia Panel (Pneumo), a diagnostic test kit for pneumonia. The product is classified as an in vitro diagnostic device (IVD) for prescription use. This recall affects 274,290 units.
The FDA has classified this as a Class II recall due to the potential for false positive results when using the pneumonia panel.
The affected product has been distributed worldwide, including throughout the United States and internationally to multiple countries. All unexpired lots bearing UDI 00815381020178 are included in this recall.
The recalled product
- Product
- FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- Affected units
- 274,290
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00815381020178/ All unexpired lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · BioFire Diagnostics, LLC
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighBioFire Joint Infection Panel diagnostic test kit contamination recall
FDA (Devices) · 2026-05-13
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighRespiratory test panels recalled over elevated risk of false negative results
FDA (Devices) · 2025-12-03
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
Same hazard · false positive
See all →- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid plasma controls recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- HighFilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives
FDA (Devices) · 2023-08-30
- HighFilmArray Pneumonia Panel diagnostic test kits recalled for false results
FDA (Devices) · 2021-06-30
- HighFilmArray Pneumonia Diagnostic Kits Recalled for False Negative Results
FDA (Devices) · 2021-07-14
- HighFilmArray Pneumonia Panel Kits Recalled Due to Shelf-Life False Negatives
FDA (Devices) · 2021-07-14
- HighBioFire Respiratory Panel 2.1 may produce false negative results
FDA (Devices) · 2023-08-30
- HighBIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect
FDA (Devices) · 2024-08-28